Organizational Policies

Name of Policy	No.
Organization Policy on Exempt Research	101.1
Organization Policy on Research Laboratory Testing Results	101.2
Organization Policy on Determination of “Human Subject Research” and Exempt Research	102.1
Organization Policy on the Definition of Research as it applies to Clinical Practice and Public Health Activities	102.2
Organization Policy on Quality Improvement/Quality Assurance Activity	102.2(a)
Organization Policy on Single Case Reports and Case Series	102.3
Organization Policy on Research Involving Human Embryonic Stem Cells, Germ Cells, and Stem Cell-Derived Test Articles	102.4
Organization Policy on Bone Marrow Transplant Procedures in Children	102.6
Organization Policy on Provision of Research Samples for Clinical Testing	102.7
Organization Policy on HSPP Assurance of Compliance with DHHS Policy	103.1
Organization Statement of Commitment to the Principles Governing Human Subjects Research	103.3
Organization Policy on List of IRB Members	103.4
Organization Policy on Meeting Procedures	103.5
Organization Policy on Reporting	103.6(a)
Organization Policy on Reports of Unanticipated Problems Involving Risks to Participants or Others	103.6(b)
Organization Policy on Reporting Death of a JHM Research Participant	103.6(b)(i)
Organization Policy on Data and Safety Monitoring of Proposed Research	103.6(c)
Organization Policy on Investigator Non-Compliance	103.7
Organization Policy on Review of Changes in Approved Research	103.9
Organization Policy on Ancillary Reviews for Human Subject Research Studies	103.10(a)
Organization Policy on Assignment of IRB Review	103.10(b)
Organization Policy on Committee on Outside Interests (COI) and the JHM IRB	103.11
Organization Policy on Human Subjects Research Compliance Training	103.12
Organization Policy on Primary Reviewer as Consent Designee for the Study Being Reviewed	103.13
Organization Policy on Transfer of Protocol among JHM IRBs	103.14
Organization Policy on Visitors to the IRB	103.15
Organization Policy on Support for the JHM IRB	103.16
Organization Policy on Policy Development and Communication	103.18
Organization Policy on Pharmacy and Therapeutics Committee and JHM IRB	103.19
Organization Policy on Drug Use and Control in Clinical Investigations	103.19(a)
Organization Policy Investigational Drug Service (IDS) and OHSR	103.20
Organization Policy on Clinical Radiation Research Committee (CRRC), the Radioactive Drug Research Committee (RDRC) and the JHM IRB	103.21
Organization Policy on Institutional Biosafety Committee (IBC) and the JHM IRB	103.22
Organization Policy on Credentials of Research Team and Documentation Required from Non-Hopkins IRBs and Study Sites	103.23
Organization Policy on Principal Investigator Responsibilities	103.24(a)
Organization Policy on Device Research Requirements	103.24(b)
Organization Policy on Registration of Clinical Trials	103.25
Organization Policy on Electronic Submission of Information to the JHM IRBs	103.26
Organization Policy on Research Funded by or Conducted with Federal Departments and Agencies	103.27
Organization Policy on IRB Composition and OHSR Staff Qualifications	107.1
Organization Policy on Consultants	107.2
Organization Policy on Training and Evaluation of IRB Members and Chairs	107.3
Organization Policy on Quorum, Voting Status of IRB Alternate Members, and JHM IRB Member Attendance	108.1
Organization Policy on Responsibility for the Human Subjects Protection Program (HRPP)	109.1(a)
Organization Policy on IRB Authority to Review Research	109.1(b)
Organization Policy on Communicating JHM IRB Actions to Investigators	109.2
Organization Policy on Complaints from Research Participants, Investigators and Research Staff, the Community, etc.	109.3
Organization Policy on Allegations of Undue Influence over the JHM IRB	109.4
Organization Policy on IRB Actions	109.5
Organization Policy on IRB Actions to Disapprove Research	109.6(a)
Organization Policy on Continuing Review of Approved Research	109.6(b)
Organization Policy on Expired JHM IRB Approval: Protocols and Consent Forms	109.7
Organization Policy on Monitoring the Consent Process and Research Procedures in Ongoing Research	109.8
Organization Policy on Expedited Review of Proposed Research	110.1
Organization Policy on Convened Meeting Primary Reviewer System	111.1
Organization Policy on Payment or Remuneration to Human Subjects	111.2
Organization Policy for Participation of Post-Doctoral Fellows In Human Subjects Research	111.3
Organization Policy on Recruitment of Employees	111.4(a)
Organization Policy on Recruitment of Students	111.4(b)
Organization Policy on Scientific Review	111.5
Organization Policy on Sedation Policies for Research Protocols Involving Diagnostic, Operative and Invasive Procedures	111.6
Organization Policy on Sample Size	111.7
Organization Policy on Research Involving Vulnerable Populations	111.8
Organization Policy on Investigators as Study Participants	111.9
Organization Policy on Minimizing Risks Associated with Research Participation	111.10
Organization Policy on Financial and Personal Conflict of Interest Policy for IRB Members	111.11
Organization Policy on Privacy and Confidentiality	111.12
Organization Policy on Recruiting Study Subjects	111.13
Organization Policy on Institutional Review of IRB Approved Research	112.1
Organization Policy on Suspension or Termination of IRB Approved Research	113.1
Organization Policy on JHM Facilitated Review for NCI Central IRB and NCI Pediatric Central IRB	114.1
Organization Policy on Cooperative Research and Multi-Center Studies	114.2
Organization Policy on IRB Records	115.1
Organization Policy on Protocol Record Retention Requirements for Investigators	115.2
Organization Policy on Informed Consent Process and Documentation	116.1
Organization Policy on Translation of Consent Documentation	116.3
Organization Policy on IRB Review of Federal-Approved Consent Documents for Federally-Supported Multicenter Clinical Trials	116.4
Organization Policy on Use of Research Data in Cases of Questionable Consent Documentation	116.5
Organization Policy on Signing the Consent/Assent Document	117.1
Organization Policy on Research Involving Pregnant Women, Human Fetuses and Neonates	B203
Organization Policy on Review of Research Involving Prisoners	C304
Organization Policy on Research Involving Children	D403
Organization Policy on Review of In Vitro Diagnostic Device Protocols (with or without Commercial Sponsors)	FDA50.1
Organization Policy on Clinical Investigations with FDA “Test Articles”	FDA 312/812
Organization Policy on Humanitarian Use Devices	FDA 814.1
Organization Policy on Investigational Drug Services Disclosures for Participant Safety Reasons	IDS.1
Organization Policy on Pathology Department Activities to Establish and Verify Laboratory Performance Specifications	PATH.1
Organization Policy on Planned Emergency Research and Requirements for Waiver of Consent in Planned Emergency Research 21 CFR 50.24; DHHS Emergency Research Consent Waiver	PER 1
Organization Policy on Incidental Findings Associated with Research Imaging Procedures	OHSR.1
Organization Policy on JHM Response to Sponsor Requests for Economic Data	OHSR.2
Organization Policy on Sponsor Responsibilities	ORA.1
Organization Policy on Prospective Reimbursement Analysis	ORA.2
Organization Policy on Tobacco Company Funding	ORA.3
Organization Policy on Maryland State Law Requirements: Maryland House Bill No. 917 (Hubbard Act)	SL1
Organization Policy on State of Maryland Mandatory Disease and Condition Reporting - Diseases and Conditions Reportable by Health Care Providers and Others	SL2
Johns Hopkins University Policy on Classified and Otherwise Restricted Research